[의료기기/인허가] RA Specialist

An international medical devices company is searching for an RA Specialist. The chosen applicant will be developing strategies for product registrations, ensuring timely submission and approval of high-quality regulatory applications.

Responsibilities:

• Develop strategies for product registrations, including license renewal, license re-evaluation, and KGMP certifications
• Ensure timely submission and approval of high-quality regulatory applications
• Provide regulatory support to the marketing team
• Ensure regulatory compliance throughout the product lifecycle
• Support internal and external audits related to regulatory affairs
• Monitor emerging regulatory trends and assess their potential impact on organisational processes
• Establish and maintain relationships with local medical device industry associations
• Build constructive and trusted relationships with local health authorities

Requirements:

• Bachelor’s degree or above in Life Sciences, Biomedical Engineering, Pharmacy, or a related field
• More than 3 years of experience in Regulatory Affairs within the medical device industry
• Knowledge and understanding of medical device regulations related to product launch
• Proficient in MS Office is preferred
• Familiarity with digital health product regulations or post-market surveillance activities is desirable
• Proficient in written and verbal English

About the Company:

An international researcher and manufacturer of medical devices, the company aims to better the lives of clients around the globe. Through careful research, they develop new processes while improving the capabilities of others, lowering risks, and raising the bar for global health.

Keywords:

의료 기기, 제조업체, 제약, 의료, 규제 업무, 국제

Job Ref: DJCI7A